Sodium Sulfacetamide 10 Sulfur 5 Cleanser
10 mg/g + 5 mg/g · Rinse
- Prescription only
- Sulfonamide Antibacterial
- Active substance
- Sulfacetamide Sodium and Sulfur
- Made by
- Acella Pharmaceuticals, LLC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2026-07-14
Sulfonamide Antibacterial
- Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
From the official label · 2026-07-14 · DailyMed
How it works
From this product’s own US prescribing label.
The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth.
While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged.
While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-07-14
Do not take it if
- Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation.
- Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is not to be used by patients with kidney disease.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- Apply Sodium Sulfacetamide 10% - Sulfur 5% Cleanser once or twice daily to affected areas, or as directed by your physician.
- Wet skin and liberally apply to areas to be cleansed.
- Massage gently into skin for 10-20 seconds, working into a full lather, rinse thoroughly and pat dry.
- If drying occurs, it may be controlled by rinsing off Sodium Sulfacetamide 10% - Sulfur 5% Cleanser sooner or using less often.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Although rare, sensitivity to sodium sulfacetaminde may occur.
- Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides.
- Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides.
- Particular caution should be employed if areas of denuded or abraded skin are involved.
- General - If irritation develops, use of the product should be discontinued and appropriate therapy instituted.
- Patients should be carefully observed for possible local irritation or sensitization during long-term therapy.
- The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis.
- These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.
- Information for patients - Avoid contact with eyes, eyelids, lips and mucous membranes.
- Carcinogenesis, Mutagenesis and Impairment of Fertility - Long-term studies in animals have not been performed to evaluate carcinogenic potential.
- PREGNANCY: Category C.
- General - If irritation develops, use of the product should be discontinued and appropriate therapy instituted.
- Patients should be carefully observed for possible local irritation or sensitization during long-term therapy.
- The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis.
- These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Category C.
- Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% - Sulfur 5% Cleanser.
- It is not known whether Sodium Sulfacetamide 10% - Sulfur 5% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
- Sodium Sulfacetamide 10% - Sulfur 5% Cleanser should be given to a pregnant woman only if clearly needed.
- It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 10% - Sulfur 5% Cleanser.
- However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk.
- In view of this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 10% - Sulfur 5% Cleanser is administered to a nursing woman.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Use in children
Safety and effectiveness in children under the age of 12 have not been established.
Quoted from the official label, section “Pediatric Use”.
Side effects
Although rare, sodium sulfacetamide may cause local irritation.
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
- -
- Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.
Quoted from the official label, section “Patient Counseling Information”.
What it looks like and how it is packed
- Sodium Sulfacetamide 10% - Sulfur 5% Topical Suspension is available in 6 oz (170.3 g) bottles, NDC 42192-136-06, 8 oz (227 g) bottles, 42192-136-08 and 12 oz (340.2 g) bottles, NDC 42192-136-12.
- Store at 20° -25°C (68°-77°F); excursions permitted to 15° - 30°C (59° -86°F). [See USP Controlled Room Temperature).
- Protect from freezing.
- KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
- All prescription substitutions using this product shall be made subject to state and federal statutes as applicable.
- NOTE:
- This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing.
- No representation is made as to generic status or bioequivalency.
- Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.
Quoted from the official label, section “How Supplied”.
How to store it
Store at 20° -25°C (68°-77°F); excursions permitted to 15° - 30°C (59° -86°F). [See USP Controlled Room Temperature). Protect from freezing.
Quoted from the official label, section “Storage and Handling”.
What is in it
- Each ml of Sodium Sulfacetamide 10% - Sulfur 5% Cleanser contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur in a formulation containing Butylated Hydroxytoluene, Cetyl Alcohol, Disodium EDTA, Disodium Oleamido MIPA Sulfosuccinate, Glyceryl Slearate, Magnesium Aluminum Silicate, Methylparaben, PEG-100 Stearate, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Cocoyl lsethionate, Sodium Melhyl Cocoyl Taurale, Sodium Thiosulfate, Stearyl Alcohol, Xanthan Gum.
- Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent.
- Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl)-acetamide, monosodium salt, monohydrate.
- The structural formula is: Chemical Structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Details
| Made by | Acella Pharmaceuticals, LLC |
|---|---|
| Active substance | Sulfacetamide Sodium and Sulfur |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Strength | 10 mg/g + 5 mg/g |
| Form | Rinse |
| Route | Topical |
| Packs | 170.3 g in 1 BOTTLE · 227 g in 1 BOTTLE |
| NDC | 42192-136 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.